Non-biologic surgical implant

ABSTRACT

A method of creating a non-biologic implant configured for implantation into a patient is provided. The method includes constructing a non-biologic three dimensional composite support structure integrally formed as one piece, the non-biologic three dimensional composite support structure including a nonbiodegradable material and having a porous construction with a plurality of passages, wherein the support structure is constructed to have a configuration corresponding to at least one of a bone and a portion of a bone to be replaced in the patient. The method also includes providing the non-biologic three dimensional composite support structure to enable placement of the non-biologic three dimensional composite support structure in the patient, wherein an outer surface of the support structure is configured to be pressed adjacent the bone, wherein the non-biologic three dimensional composite support structure is configured to be positioned in the body to promote growth of tissue in the body of the patient into at least a portion of the non-biologic three dimensional composite support structure by having at least a portion of the porous construct adjacent the bone enabling biologic structures to grow into the plurality of passages in the porous construction to securely connect the support structure in place in the body of the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/080,113, filed Mar. 24, 2016, which is a continuation of U.S. patentapplication Ser. No. 13/912,933, filed Jun. 7, 2013, which is acontinuation of U.S. patent application Ser. No. 13/912,717, filed Jun.7, 2013, which is a continuation of U.S. patent application Ser. No.11/926,609, filed Oct. 29, 2007, which is a continuation of U.S. patentapplication Ser. No. 10/457,100, filed Jun. 6, 2003, now U.S. Pat. No.7,299,805, which claimed the benefit under 35 U.S.C. §119(e) ofProvisional Application No. 60/387,013 filed Jun. 7, 2002, each of whichis hereby incorporated by reference in its entirety.

BACKGROUND

The present invention relates to the implanting of cells into a body ofa patient, and in particular to the implantation of viable cells on ascaffold or support structure.

Various organs or other tissue in a patient's body may become defectivedue to trauma, disease, or other causes. Transplanting of organs and/ortissue has been utilized for the treatment of defective organs. However,problems have been encountered in securing an adequate number ofsuitable donor organs. It is believed that it may be desirable to have apatient grow a replacement organ, portion of an organ, or other bodytissue for replacement of any defective tissue, organ, or portionthereof.

SUMMARY

The present invention relates to a method of implanting viable cellsinto a body of a patient. The viable cells may be positioned on asupport structure. One or more blood vessels in a patient's body may beconnected with the support structure at one or more locations. Theviable cells on the support structure may be exposed to blood flow inthe support structure. One or more support structures may be providedand positioned in the patient's body.

The support structure may be formed in many different ways. One way inwhich the support structure may be formed is by removing an organ or aportion of an organ from a body, either the patient's own body oranother body. Cells and/or other tissue may be removed from the organ orportion of an organ to leave a collagen matrix support structure havinga configuration corresponding to the configuration of the organ orportion of an organ. Viable cells are positioned on the collagen matrixsupport structure. The support structure, which has a configurationcorresponding to the configuration of an organ or portion of an organ,is positioned in the patient's body with the viable cells disposed onthe support structure. Blood vessels may be connected with the supportstructure as it is positioned in the patient's body.

The support structure may be formed by using an organ or portion of anorgan from a body that is either the patient's body or another body as apattern. Alternatively, the pattern may be synthetically constructed tohave a configuration corresponding to the general configuration of anorgan or portion of an organ in a patient's body. The pattern may be atleast partially enclosed with mold material. The pattern and moldmaterial are subsequently separated to leave a mold cavity. Thesynthetic support structure is subsequently shaped in the mold cavity.The synthetic support structure may be formed as a unitary member orformed by one or more intertwined strands.

One or more expandable members may be utilized to align an implant andtissue in a patient's body. For example, one or more balloons may beutilized to align a portion of a blood vessel with a segment which is tobe implanted into the blood vessel.

It should be understood that the present invention has a plurality ofdifferent features which may be utilized separately or in variouscombinations. It is also contemplated that the various features of theinvention may be utilized with known features from the prior art.Although specific combinations of features have been described herein,it is contemplated that other combinations of features will be apparentto those skilled in the art and will be formed.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the invention will become moreapparent upon a consideration of the following description taken inconnection with the accompanying drawings wherein:

FIG. 1 is a schematic illustration depicting the manner in which asupport structure is connected with portions of one or more bloodvessels in a patient's body;

FIG. 2 is a fragmentary schematic plan view, taken generally along theline 2-2 of FIG. 1, illustrating in the manner in which viable cells maybe positioned on the support structure of FIG. 1 and exposed to a flowof blood through the support structure;

FIG. 3 is a schematic illustration, generally similar to FIG. 2,illustrating in the manner in which a barrier may be used to direct theflow of blood through a support structure;

FIG. 4 is a fragmentary schematic sectional view, generally similar toFIG. 3, depicting the manner in which a plurality of blood vessels areconnected with a support structure containing a barrier to direct a flowof blood through the support structure and to disperse the flow of bloodin the support structure;

FIG. 5 is a schematic illustration of an organ, that is, a kidney, in apatient's body;

FIG. 6 is a schematic illustration depicting the manner in which aplurality of the support structures of FIGS. 1-4 may be positioned inthe organ of FIG. 5;

FIG. 7 is a schematic illustration depicting the manner in which anorgan or model of an organ may be used as a pattern to form a moldcavity in which a synthetic support structure may be formed;

FIG. 8 is a schematic illustration depicting the manner in which asupport structure on which viable cells are disposed is utilized toreplace a portion of a blood vessel;

FIG. 9 is a schematic illustration depicting the manner in which aballoon is utilized to align the support structure and portions of ablood vessel;

FIG. 10 is a schematic illustration, generally similar to FIG. 9,illustrating the manner in which a plurality of balloons may be utilizedto align the support structure and portions of a blood vessel;

FIG. 11 is a top view of an embodiment of a support structure in theform of a three dimensional mesh of fibers.

DETAILED DESCRIPTION General Description

An implant 20 is illustrated schematically in FIGS. 1 and 2. The implant20 includes a support structure or matrix 22 (FIG. 2) which may have anydesired configuration. A plurality of viable cells 24 (FIG. 2) arepositioned on the support structure 22. Although the support structure22 has been illustrated schematically in FIGS. 1 and 2 as having arectangular configuration and the viable cells 24 have been illustratedschematically as being disposed in a rectangular array on a rectangularmatrix, it is contemplated that the support structure 22 could have anydesired configuration and that the viable cells 24 could be disposed inany desired arrangement on the support structure.

In accordance with one of the features of the present invention, one ormore blood vessels 28 are connected with the support structure 22 toprovide for a flow of blood through the support structure. Although thesupport structure 22 may be connected with blood vessels 28 in manydifferent ways, in the specific arrangement illustrated in FIGS. 1 and2, an arteriole (a small artery) 32 and a venule (small vein) 34 areconnected with the support structure 22. This results in a flow of bloodfrom left to right, as indicated by arrows in FIGS. 1 and 2, through theimplant 20. The viable cells 24 are exposed to the flow of blood.

Although the implant 20 has been illustrated in FIGS. 1 and 2 as beingconnected with an artery 32 and vein 34, it is contemplated that theimplant 20 could be connected with one or more arteries or one or moreveins. Thus, a portion of the same artery or vein may be connected withopposite sides of the implant 20. Alternatively, a portion of one arteryor vein may be connected with one side of the implant 20 and a portionof another artery or vein may be connected with the opposite side of theimplant.

If desired, a plurality of portions of arteries and/or veins may beconnected with one side of the implant 20. Similarly, a plurality ofportions of arteries and/or veins may be connected with the oppositeside of the implant 20. The number of portions of arteries and/or veinsconnected with the implant 20 will vary depending upon the locationwhere implant 20 is to be positioned in a patient's body. The patient isa living human.

The interior of the support structure 20 has a plurality of passagesthrough which blood may flow. It is contemplated that capillaries,arterioles, and/or venules may grow in the support structure 20. Theouter sides of the support structure 20 may be formed of a materialwhich is impervious to blood or a material which restricts the flow ofblood from the implant 20 to surrounding tissue.

The implant 20 may be positioned at any desired location in a patient'sbody. For example, the support structure 22 may be positioned in anorgan, that is, a functional unit of cells. The organ in which thesupport structure 22 is positioned may be a heart, blood vessel, brain,intestine, stomach, adrenal gland, liver, pancreas, skeleton, spinalcord, or other organ. The support structure 22 may be positioned ineither soft tissue or hard tissue.

The support structure 22 may have a configuration corresponding to theconfiguration of an entire organ or a portion of an organ. If thesupport structure 22 has a configuration corresponding to theconfiguration of a portion of an organ, a plurality of the supportstructures 22 may be positioned in an organ. The support structures 22may be positioned adjacent to each other and/or spaced apart from eachother in the organ. Although it may be desired to position the supportstructure 22 in an organ, the support structure may be positioned atother locations in a patient's body.

The support structure 22 may be positioned in a patient's body by fiberoptic surgery, such as arthroscopic or laproscopic surgery. It iscontemplated that an imaging apparatus and/or a robotic mechanism may beused in positioning the support structure. This may include moving thesupport structure through a cannula in the manner disclosed in U.S.patent application Ser. No. 10/102,413 filed Mar. 20, 2002 by Peter M.Bonutti and entitled Methods of Securing Body Tissue. The implant 20 maybe connected with tissue in a patient's body in any one of the waysdisclosed in the aforementioned application Serial No. 10/102,413, whichis incorporated herein.

The support structure 22 may be formed in many different ways and ofmany different materials. The specific manner in which the supportstructure 22 is formed will be influenced, to some extent at least, bythe location at which the support structure is to be positioned in thepatient's body. In addition, the manner in which the support structureis formed will depend upon the overall size of the support structure andwhether or not it is to be formed of biodegradable or nonbiodegradablematerial.

The support structure 22 may be integrally formed as one piece and havea porous construction with openings in which viable cells 24 arepositioned. Alternatively and as shown in FIG. 11, the support structuremay be formed by intertwining one or more strands (filaments) of adesired material. The viable cells 24 will be positioned in openingsdisposed between the intertwined strands.

The support structure 22 may be formed of a hydrophilic material whichabsorbs body fluid when the support structure 22 is positioned in apatient's body. When the support structure absorbs body fluid, itexpands and presses against adjacent body tissues to promote theformation of a mechanical interlock between the support structure 22 andadjacent body tissues. As the hydrophilic material of the supportstructure absorbs liquid from the patient's body, the volume of thesupport structure 22 increases. The resulting expansion of the supportstructure 22 presses the support structure against adjacent body tissue.As this occurs, the material of the support structure 22 and theadjacent tissue are pressed firmly against each other to form aconnection between the support structure and the adjacent tissues.

The formation of a mechanical interlock may also be promoted bycompressing the support structure 22 before insertion of the supportstructure into the patient's body. When this is done, the supportstructure forms a mechanical interlock with tissue due to the combinedeffects of absorbing fluid and resiliently expanding.

The support structure 22 may be formed of a polymeric material whichabsorbs body liquid. The polymeric material may be either a copolymer ora dipolymer. The polymeric material may be natural or syntheticcollagen. If desired, the polymeric material may be cellulose,petroylglutamic acid, high purity carboxymethylcellulose, orpolylactide. Of course, the support structure 22 may be formed of otherknow material which absorbs body liquid. The support structure 22 may beformed of materials disclosed in U.S. Pat. No. 6,152,949 and form aninterlock with adjacent body tissues in the manner disclosed in thatpatent.

The implant 20 may be formed as an entire organ or as a portion of anorgan. When this is the situation, the support structure 22 may beformed by removing an entire organ or a portion of an organ from a body.The body from which the organ is removed may be either the patient'sbody or another body.

Once the entire organ or portion of an organ has been removed from abody, cells and/or other tissue may be removed from the organ to leave asupport structure 22 having a configuration corresponding to theconfiguration of the organ or portion of an organ. The support structure22 may include a collagen matrix formed by tissue of the organ orportion of an organ removed from a body.

Rather than using an organ or a portion of an organ removed from a bodyto form the support structure 22, the organ or portion of an organ maybe used as a pattern in the formation of a synthetic support structure.The synthetic support structure 22 may be either biodegradable ornonbiodegradable. The synthetic support structure 22 may be molded orwoven to have a configuration corresponding to the configuration of theorgan or portion of an organ. It is contemplated that the syntheticsupport structure 22 may have a composite construction and be formed ofdifferent materials which have different characteristics.

It is contemplated that the viable cells 24 may be any desired type ofviable cells. It is contemplated that the viable cells 24 may correspondto cells which were in a damaged organ or other portion of a patient'sbody. More than one type of viable cell 24 may be positioned on the samesupport structure 22. The support structure 22 and viable cells 24 maybe positioned in either hard or soft tissue.

When the support structure 22 is to be positioned in an organ, it iscontemplated that the viable cells 24 on the support structure 22 willhave characteristics associated with the characteristics of normal cellsin the organ in which the support structure is to be positioned. Manyorgans contain cells which have different characteristics and performdifferent functions within the organ. It is contemplated that the viablecells 24 on the support structure 22 may have different characteristicscorresponding to the different characteristics of cells of an organ.When the support structure 22 is to be positioned outside of an organ,the cells positioned on the support structure may have any desiredcharacteristic or combination of characteristics.

It is also contemplated that the viable cells can be pluripotent cellsthat are directed to differentiate into the desired cell type or types.One example of such cells is stem cells. The differentiation can becontrolled by applying or exposing the cells to certain environmentalconditions such as mechanical forces (static or dynamic), chemicalstimuli (e.g. pH), and/or electromagnetic stimuli.

More than one type of cell may be positioned on the support structure22. The type of cell positioned at a particular location on the supportstructure 22 will be determined by the orientation of the supportstructure in a patient's body and by the specific type of tissue desiredat a particular location in a patient's body. For example, stromal cellsmay be positioned at a location where foundation tissue is desired andanother type of cell may be positioned at locations where it is desiredto have tissue perform a special function.

As previously noted, the present invention envisions harvesting andculturing cells prior to placement within the support structure 22.Although most researchers tend to isolate and grow one basic cell line,it may be beneficial to mix multiple different cell lines together. Forexample, embryonic cells or fetal cells can be used to grow cartilage orany desired tissue (such as liver or pancreas) and these can be combinedwith the mature cells of an older individual. The older individual caneither be the patient receiving the mixed cells or possibly anotherhealthier individual. Regardless of the source, the net result is acombination of two cell populations, one younger and more vibrant andanother which is older, more mature. The younger cells may have more ofan ability to differentiate into the desired cell type, while the oldercells may have more of the regulatory factors, tissue inductive factors,etc, which would be more likely to guide and control the younger cells.

Growth factors or other therapeutic agents can be added to either orboth of the cell types. The addition of the agents can be before and/orafter combining the cells. Examples of growth factors that can be usedinclude insulin-like growth factor (IGF-1), fibroblast growth factor(FGF), transforming growth factor (TGF-β), hepatocyte growth factor(HGF), platelet-derived growth factor (PDGF), Indian Hedgehog (Inh) andparathyroid hormone-related peptide (PTHrP), bone morphogenetic proteins(BMPs), and Interleukin-1 receptor antagonist (IL-1ra).

There are many different types of cells which may be positioned on thesupport structure 22. These cells include progenitor cells whichdifferentiate and proliferate to form cells having desiredcharacteristics; stromal cells which relate to foundation supportingtissue; and mesenchymal cells which relate to connective tissues, bloodand blood vessels, and other systems. Fibroblasts may be used in theproduction of connective tissues. Osteoblasts may be used in theproduction of hard tissue (bone). Myoblasts may be used in theproduction of muscle.

Specific cells may be used to provide for growth of tissue having afunction associated with the cell. These cells may include reticularcells, smooth muscle cells, chondrocytes, retinal cells, endothelialcells, and other known cells.

For example, if cardiac tissue is desired, the cells can includeendocardial, myocardial, and pericardial cells. These cells can belayered or otherwise arranged. If cartilage and bone tissue is desired,a combination of chondrocytes (and/or chondroblasts) and osteoblasts, ortheir precursors can be used.

One source of precursor cells is bone marrow, which contain progenitorcells. These progenitor or stem cells can be treated so as todifferentiate into any desired cell type.

Although the present invention anticipates that the cells can beharvested in any desired fashion, and are accordingly not discussed indetail herein, the harvesting of fetal cells deserves special note.Fetal cells can be harvested directly from the fetus in situ usingminimally invasive techniques or through procedures such asamniocentesis, chorionic villus sampling (CVS), and other similarmethods that do not involve invasive contact with the fetus. Regardlessof the harvesting method, image guidance (MRI guidance, ultrasonicguidance, etc) can be used. Computer assisted techniques can be used inconjunction with the image guidance. Additionally, the harvesting can beperformed using a robotic or haptic system.

If desired, specific types of fetal cells such as liver, pancreas, orrenal cells, etc, could be selectively harvested. The fetus does notnecessarily have to be harmed during the harvesting, but can be keptviable. Thus, the fetus does not have to be aborted after obtaining thecells, but actually could be left alive and could be a source for cellspossibly through one or multiple aspirations while the fetus is stillgrowing. For example, one may require multiple aspirations of livercells or neural cells, with multiple cell types at various levels ofmaturation for the desired graft.

Implant

The implant 20 includes the support structure 22 on which the viablecells 24 are disposed. The viable cells 24 are exposed to a flow ofblood between the blood vessels 32 and 34. The blood vessels 32 and 34are connected with the support structure 22. The blood flows through theblood vessels 32 and 34 in the manner indicated by arrows in FIGS. 1 and2.

It is contemplated that the blood vessels 32 and 34 may be connectedwith a support structure 22 in any desired manner. In the specificembodiment illustrated schematically in FIGS. 1 and 2, an end portion ofthe arteriole 32 is stitched to the support structure 22. Similarly, anend portion of the venule 34 is stitched to the support structure 22. Inaddition to being connected with the blood vessels 28, the implant 20may be retained in tissue in a patient's body by stitching the supportstructure 22 to the tissue in the patient's body.

It is contemplated that the blood vessels 28 may be connected with thesupport structure in many different ways. For example, the arteriole 32may be connected with the support structure 22 by an adhesive such ascyanoacrylate (so-called “superglue”), Polylatic acid, or fibrin.Additionally, the modified biofilm discussed below in connection withthe attachment of cells to the support structure 22 can be used tocouple the arteriole 32 and the support structure 22. Of course, the endportion of the venule 34 may be connected with the support structure 22by an adhesive in the same manner as in which the arteriole 32 isconnected with the support structure. It should be understood that theblood vessels 32 and 34 could both be arterioles or venules if desired.

To facilitate connecting the arteriole 32 and venule 34 with the supportstructure 22, appropriately shaped and sized recesses may be provided inthe support structure 22. These recesses would have an inside dimensionwhich is only slightly larger than the outside diameter of the arteriole32 and/or venule 34. The arteriole 32, for example, would betelescopically inserted into the cylindrical recess in the supportstructure 22. The joint between the support structure and the exteriorsurface of the arteriole 32 may be sealed with a suitable sealant. It iscontemplated that an adhesive could be utilized as the sealant.

In the embodiment illustrated in FIGS. 1 and 2 the arteriole 32 andvenule 34 are shown as being axially aligned with each other, that is,they are in a coaxial relationship. However, it is contemplated that thearteriole 32 could be offset to one side, for example, to the left, andthe venule 34 offset to the opposite side, for example, to the right, ofthe central axis of the support structure 32. This would promote adispersion of the flow of blood from the arteriole in the supportstructure 22 before the flow of blood entered the venule 34. Of course,this would increase the exposure of the viable cells 24 to the flow ofblood.

If desired, the arteriole 32 could be inserted for a substantialdistance, into the support structure 22 and the venule 34 inserted for asubstantial distance into the support structure 22. If this was done, itis contemplated that the arteriole 32 would be offset from the venule34. Thus, the arteriole 32 could be offset downward (as viewed in FIG.2) and the venule 34 offset upward (as viewed in FIG. 2) so that theyare not in axial alignment with each other.

By telescopically inserting the arteriole 32 into a cylindrical recessor hole in the support structure 22 for a distance which is more thanone half of the thickness of the support structure, the flow of bloodwould exit the arteriole adjacent to the side of the support structurefrom which the venule 34 extends, that is, the right side of the supportstructure 22 (as viewed in FIG. 2). Similarly, the venule 34 wouldextend telescopically into a recess which extends past the center of thesupport structure 22. This would result in the flow of blood in thesupport structure 22 entering the venule 34 adjacent to the left (asviewed in FIG. 2) side of the support structure 22.

If this was done, the arteriole 32 and venule 34 would not be axiallyaligned with each other but would be offset so that the blood would flowfrom the arteriole 32 in a reverse direction, that is toward the left asviewed in FIG. 2, to the entrance to the venule 34. This would result inthe arteriole 32 and venule 34 being disposed in a side-by-side andoffset relationship relative to each other in the support structure 22.The blood would flow from the end of the arteriole 32 adjacent to theright (as viewed in FIG. 2) side of the support structure 22 to the endof the venule 34 adjacent to the left (as viewed in FIG. 2) side of thesupport structure. The resulting nonlinear flow of blood between thearteriole 32 and venule 34 would promote dispersion of the blood in thesupport structure 22 and promote exposure of the viable cells 24 to theflow of blood.

In the embodiment illustrated in FIGS. 1 and 2 the arteriole 32 andvenule 34 are connected directly to the support structure 22. However,it is contemplated that the support structure 22 could be provided witha pair of conduits which are connected between an artery and vein in apatient's body. Thus, the support structure 22 may be provided with atubular conduit in place of the arteriole 32 of FIGS. 1 and 2 and atubular conduit in place of the venule 34. The tubular conduit whichreplaces the arteriole 32 would be connected with an artery in thepatient's body and the tubular conduit which replaces the venule 34would be connected with a vein in the patient's body. The tubularconduits which extend from the support structure 22 may be formed of asynthetic material or may be formed by veins and/or arteries harvestedfrom the patient's body or from another body.

A plurality of support structures 22 may be implanted into a patient'sbody. If this is done, the plurality of support structures 22 may beinterconnected by conduits before being placed in the patient's body.The plurality of the support structures 22 may be interconnected to haveparallel and/or series flow of blood through the support structures 22.

It is contemplated that feeder conduits could extend from a manifoldconduit to conduct a flow of blood to each support structure 22 of aplurality of support structures. If this is done, a second plurality offeeder conduits may extend from a second manifold conduit to each of thesupport structures to conduct a flow of blood from the plurality ofsupport structures. The first manifold conduit may be connected in fluidcommunication with an artery in a patient's body and the second manifoldconduit may be connected with a vein in a patient's body. This wouldenable a plurality of support structures 22 to be supplied with bloodconducted from a single connection between the first manifold conduitand an artery. Similarly, blood would flow from the plurality of supportstructures 22 to a vein through a single connection between a vein andthe second manifold conduit. If desired, the first and second manifoldconduits could both be connected with either an artery or a vein.

It is believed that interconnecting a plurality of support structures 22with suitable conduits before the support structures are positioned in apatient's body will facilitate positioning of the support structures.This is because the number of connections which have to be made betweenthe support structures 22 and the blood vessels in the patient's bodywould be minimized. When a plurality of support structure are utilizedthey may be interconnected in a parallel blood flow arrangement in themanner previously described or in a series blood flow arrangement beforebeing positioned in the patient's body.

It is contemplated that the sides of the support structure 22 may beconstructed as to retard a flow of blood from the support structure.Thus, the support structure 22 may be constructed with outer sidesurfaces that effectively block a flow of blood from the supportstructure through the outer side surfaces of the support structure.Alternatively, the outer sides of the support structure 22 may beprovided with very small openings which effectively retard, withoutcompletely blocking, a flow of blood through the sides of the supportstructure. In another embodiment, the sides of the support material 22are made of a material that has one-way permeability. This would eitherallow absorption of blood while preventing discharge, or allow blooddischarge while preventing absorption.

If the side walls 40 are effective to block the flow of blood from thesupport structure 22, all of the blood which enters the supportstructure 22 from the arteriole 32 (FIGS. 1 and 2) would flow from thesupport structure through the venule 34. However, if the side walls 40are somewhat porous so that they are effective to retard or onlypartially block a flow of blood through the side walls 40, a portion ofthe blood from the arteriole 32 would flow from the support structure 22through the side walls 40 of the support structure while the remainderof the blood from the arteriole 32 would flow from the support structurethrough the venule 34. By allowing some, but not all, of the blood toflow from the support structure 22 through the side walls 40, dispersionof blood within the support structure is promoted.

It is contemplated that minute passages may be provided in the supportstructure 22 to accommodate the growth of capillaries within the supportstructure. Thus, a network or web of capillaries may grow in the supportstructure 22 between the arteriole 32 and venule 34. This network ofcapillaries would facilitate supplying blood to all of the viable cells24 within the support structure 22. The side walls 40 (FIG. 1) of thesupport structure 22 may have small openings through which capillariesgrow between the support structure and surrounding tissue in thepatient's body.

In the embodiment of the invention illustrated in FIGS. 1 and 2, asingle arteriole 32 is connected with a support structure 22 to conductblood to the support structure and a single venule 34 is connected withthe support structure to conduct blood from the support structure. It iscontemplated that a plurality of arterioles 32 and/or venules 34 may beconnected with the support structure 22. Thus, a plurality of arterioles32 may be connected with a first side wall 40 of the support structure22 to conduct a flow of blood into the support structure at a pluralityof locations. Similarly, a plurality of venules 34 may be connected witha second side wall 40 of the support structure 22 at a plurality oflocations to conduct blood from the support structure. The number ofarterioles 32 connected with the support structure 22 may be the sameas, greater than, or less than the number of venules 34 connected withthe support structure.

When it is desired to conduct blood to and from the support structure 22along a plurality of flow paths, it is believed that it may be desiredto connect a plurality of conduits with the support structure before thesupport structure is positioned in the patient's body. Thus, at alocation remote from an operating room, a plurality of conduits may beconnected with one of the side walls 40 of the support structure 22.These conduits may all be connected with a single relatively largeconduit. This relatively large conduit would be connected with an arteryin a patient's body in an operating room. Similarly, a plurality ofconduits may be connected with a second side wall of the supportstructure 22 and be connected with a second single conduit. This singleconduit may be connected with a vein in a patient's body in an operatingroom. This would minimize the number of connections which would have tobe made with the support structure 22 during a surgical procedure in anoperating room and would enable most of the connections to be made in aless stressful environment remote from the operating room.

Tissue inductive growth factors and/or other therapeutic agents may beprovided on the support structure 22 to promote a growth of tissuebetween the patient's body and the support structure 22. The tissuegrowth inductive factors may promote a growth of blood vessels, such ascapillaries, between tissue and the patient's body and the supportstructure 22. The tissue inductive growth factors may also promote thegrowth of connective tissue between the support structure 22 and thetissue in the patient's body to securely connect the support structurein place in the patient's body.

Other additives include materials such as plasticizers, citrate esters,hexametholsebacate, antibiotics (e.g., tetracyclines, penicillins,mefronidazole, clindamycin, etc.), to prevent infection, etc., or toaccomplish other desired conditions or results. Additional additives ortherapeutic agents include osteoinductive, biocidal, or anti-infectionsubstances. Suitable osteoinductive substances include, for example,growth factors. The growth factors may be selected from the group of IGF(insulin-like growth factors), TGF (transforming growth factors), FGB(fibroblast growth factors), EGF (epidermal growth factors), BMP (bonemorphogenic proteins), and PDGF (platelet-derived growth factors).

The therapeutic agent(s) may be contained within the material of thesupport structure 22. Alternatively, the agent(s) may be disposed in astructure which is separate from the support structure 22. For example,tissue inductive growth factors could be disposed in a collagen spongewhich is positioned adjacent to the support structure 22 in thepatient's body. Alternatively, the agent(s) may be positioned in astructure which is connected to the support structure 22.

It is believed that it may be advantageous to have a slow release of theagent(s) adjacent to the patient's body tissue and the viable cells 24.The agent(s) could be held in a biodegradable container or containerswhich degrade over a period of time and slowly release the agent(s).

In order to promote the attachment of the viable cells to the supportstructure 22, the support structure 22 can be pretreated with an agentthat promotes cell adhesion. One such agent is an organic substancebased on a biofilm. A biofilm is a slimy, glue-like substance that formswhen bacteria attach to surfaces exposed to water. Typically, coloniesof biofilm bacteria are unwanted as they carry out a variety ofdetrimental reactions. However, a sterile biofilm may be used to promoteinitial attachment of cells to the support structure 22.

The sterile biofilm could be engineered to isolate the glue-likesubstance while eliminating the adverse properties of the bacteria. Theresulting sterile glue-like substance would be used to help the cellsstick to the support structure 22. The engineered biofilm could be addedto the support structure 22 in the laboratory that produces the supportstructure or just prior to the addition of the cells by the user.Alternatively, the biofilm and support structure could be combinedintra-corporally.

This biofilm also could be used as an independent polysaccharide basedadhesive with mild to moderate adhesion forces. The biofilm could serveas a surgical adhesion or grouting for cells, for tissue fixation (softtissue to soft tissue, soft tissue to bone, etc.) and as a sealant.

In addition to coating the support structure 22, the biofilm could beused in conjunction with other implants and devices. For example, thebiofilm could be used to coat a stent. Although the biofilm mightdegrade in vivo, the coating could serve as a top coat covering a layerof a therapeutic agent or be impregnated with the therapeutic agent.Thus, as the coating dissolves, the agent is delivered locally in atime-released fashion.

It is contemplated that the support structure 22 may be formed of abiodegradable material. The biodegradable material would at leastpartially degrade after the patient's body tissue has grown into thesupport structure 22. The support structure 22 may be formed of aplurality of materials. Some of these materials may be biodegradable andsome of the materials may not be biodegradable. But by forming thesupport structure 22 as a composite of both biodegradable andnonbiodegradable materials, a portion of the support structure woulddegrade with passage of time while another portion of the supportstructure would remain.

When the support structure 22 is formed entirely of biodegradablematerials, it is contemplated that portions of the structure may degradebefore other portions. Thus, one portion of the support structure 22 maybe formed of material which degrades over a relatively long period oftime while other portions of the support structure 22 may be formed ofmaterials which degrade over a shorter period of time. The provision oftissue inductive growth factors on the support structure would promotethe growth of tissue into the support structure during the degradationof material of the support structure.

It is contemplated that the support structure 22 may be relatively largeand provide for growth of a substantial volume of tissue in a patient'sbody. Alternatively, the support structure 22 may be relatively small.If a relatively small support structure 22 is utilized, it is believedthat a plurality of the support structures may be positioned in apatient's body. The individual support structures of the plurality ofsupport structures may be positioned adjacent to each other or spacedapart from each other.

When the implant 20 is to be positioned relative to the body tissue, theimplant may be moved through a cannula, such as the expandable cannuladisclosed in U.S. Pat. No. 6,338,730, into the body tissue. An openingfor the support structure 22 may be formed in the body tissue utilizingminimally invasive surgical techniques similar to those disclosed inU.S. Pat. No. 6,174,313. The surgical techniques may involve moving oneor more devices through an expandable cannula into the body tissue. Thedevices moved into the patient's body may be guided by using magneticresonance imaging systems, ultrasonic imaging apparatus, fluoroscopicapparatus and/or other imaging techniques. The fluoroscopic apparatusmay have a construction similar to that disclosed in U.S. Pat. Nos.5,099,859; 5,772,594; 6,118,845 and/or 6,198,794. A plurality ofendoscopes may be utilized to generate stereoscopic images, that is,three dimensional images, of an area where the implant 20 is to bepositioned. The endoscopes and other imaging devices may be utilized ina manner which is the same as is disclosed in U.S. patent applicationSer. No. 10/102,413 filed Mar. 20, 2002 by Peter M. Bonutti and entitledMethod of Securing Body Tissue.

During the performance of surgical procedures, a drapery system whichextends between the patient and the surgeon may be utilized. The draperysystem may include a drape which is either integrally formed as onepiece with a surgeon's gown or is formed separately from the surgeon'sgown and is connected with the surgeon's gown. The drapery systemmaintains a sterile field which extends from the surgeon to spaceadjacent to the patient. This enables the surgeon to move relative tothe patient without contaminating the sterile field. The drapery systemmay be constructed in the manner disclosed in U.S. patent applicationSer. No. 10/263,893 filed Oct. 3, 2002 by Peter M. Bonutti and entitledSurgical Draping System.

If a plurality of relatively small support structures 22 are to bepositioned in a patient's body, it is believed that it may be desired tointerconnect the plurality of support structures with a network ofconduits prior to insertion of the support structures into the patient'sbody. Thus, a relatively large number of support structures 22 may beinterconnected by a web of conduits. The resulting mesh or networkformed of the plurality of small support structures 22 and conduits maybe loosely positioned over soft tissue in a patient's body. Each of thesupport structures 22 may then be individually implanted or moved intosoft body tissue. The webbing of conduits would extend between theindividual support structures 22. The webbing of conduits would then beconnected with the patient's vascular system.

By having a relatively large number of small support structures 22interconnected by a webbing or network of conduits before the supportstructures are positioned relative to a patient's body, the number ofconnections to the patient's vascular system for a relatively largenumber of support structures would be minimized. The webbing or networkof support structures 22 would be anchored in the patient's body tissueat each location where a support structure was implanted. The webbing ofconduits would be effective to conduct a flow of blood to and from thevarious support structures 22 in the network.

As previously discussed, it should be understood that the viable cells24 in the plurality of support structures 22 interconnected by thenetwork of blood conduits may be the same type of cells or differenttypes of cells. It is believed that it may be particularly advantageousto have different types of cells in at least some of the supportstructures 22. For example, one of the support structures 22 may containviable endocrine cells and another support structure may contain viablestromal cells. Still another support structure may contain viableendothelial cells.

It should also be understood that a plurality of different types ofcells may be provided in a single support structure 22. Thus, viableendocrine cells, viable stromal cells, and viable endothelial cells mayall be provided in one support structure 22 of the plurality of supportstructures interconnected by a network of conduits which conduct bloodto the support structures.

It is contemplated that the support structure 22 may be configured so asto provide for the positioning of a layer of viable cells 28 in apatient's body. The viable cells may be allograft mesenchymal cellsand/or stem cells.

Blood Flow

In the embodiment of the invention illustrated in FIGS. 1 and 2, theflow of blood is conducted from the arteriole 32 to the supportstructure 22 and from the support structure to the venule 34. Thesupport structure 22 contains a matrix of viable cells 24 (FIG. 2). Inthe embodiment of the invention illustrated in FIG. 3, blood flow withinthe support structure 22 is controlled to maximize the exposure of theviable cells 24 to the flow of blood.

In the embodiment of the invention illustrated in FIG. 3, an implant 20includes a support structure 22. Blood vessels 28 are connected with thesupport structure 22. The blood vessels 28 include an arteriole 32 and avenule 34. In the embodiment of FIG. 3, the arteriole 32 and venule 34are connected to the same side wall 40 of the implant 20. In order tomaximize exposure of the viable cells 24 to a flow of blood, a barrier48 (FIG. 3) is provided in the support structure 22. The barrier 48 iseffective to direct the flow of blood in the support structure 22. Thebarrier 48 may extend between and be connected with opposite side walls40 of the support structure 22. Alternatively, the barrier 48 may bespaced from the side walls of the support structure.

It is contemplated that the barrier 48 may be formed of either amaterial which is impervious to a flow of blood or a material havingsmall openings through which blood can flow. If the barrier 48 isprovided with small openings through which blood can flow, the openingswould be small enough to retard a flow of blood through the barrier. Itis contemplated that barrier 48 may be integrally formed as one piecewith a support structure 22 or formed separately from the supportstructure and mounted in the support structure.

The flow of blood from the arteriole 32 cannot readily move upward (asviewed in FIG. 3) through the barrier 48. Therefore, the blood will flowdownward towards the viable cells 24 in the lower portion of the supportstructure 22. The blood from the arteriole 32 will subsequently flowupward from the lower portion of the support structure toward the upperportion of the support structure. When the blood is has moved around theright (as viewed in FIG. 3) end of the barrier 48, the blood can flowupward through the upper portion of the support structure 22. The upperportion of the support structure 22 is connected with the venule 34which conducts the flow of blood from the support structure 22 to avein.

With the specific arrangement of the barrier 48, arteriole 32 and venule34 illustrated in FIG. 3, it is believed that it would be desired toform the lower side wall 40 of the support structure 22 of a materialwhich blocks or at least substantially blocks a flow of blood. It mayalso be desired to have the upright (as viewed in FIG. 3) side walls 40of the retainer of support structure 22 formed of a material whichblocks or at least partially blocks a flow of blood. This constructionwould tend to promote the flow of blood from the lower portion of thesupport structure 22 to the upper portion of the support structure.

It is contemplated that the barrier 48 may be constructed of a pluralityof members which are either interconnected or spaced apart to cause theblood to flow along a convoluted path between the arteriole 32 andvenule 34 of FIG. 3. The barrier 48 may be constructed with a pluralityof bends which cause the blood to flow from the arteriole 32 through amaze in the support structure 22 to promote the flow of blood past eachof the viable cells 24. When the barrier 48 has such an extendedirregular configuration, it may be desired to form the barrier 48 of amaterial through which the blood can flow between various turns andpassages in the maze formed within the support structure 22. With apassage of time, it is believed that capillaries may tend to grow inmicron size passages in the support structure 22.

In the embodiments of the invention illustrated in FIGS. 1-3, thesupport structure 22 has been illustrated as having a polygonalconfiguration, specifically a rectangular configuration. However, it iscontemplated the support structure 22 could have a differentconfiguration if desired. For example, rather than the cubicleconfiguration illustrated in FIGS. 1-3, the support structure could havea configuration of a polyhedron with generally flat sides.Alternatively, the support structure 22 could have a spherical, oval, orovoid configuration. The specific configuration of the support structure22 is a function, in part at least, of a location where the supportstructure is to be positioned in a patient's body. Of course, theconfiguration of the side walls 40 of the support structure 22 will havean influence on the configuration on the barrier 48. It should beunderstood that the barrier 48 may have an arcuate configuration and maybe formed as a portion of a sphere or cylinder.

Alternative Implant

In the embodiments of the invention illustrated in FIGS. 1-3, the samenumber of conduits are utilized to conduct blood to the implant as areused to conduct blood from the implant. Thus, a single arteriole 32 anda single venule 34 are connected with a support structure 22 which has arelatively simple cubicle construction. A simple one piece barrier 48has been illustrated in FIG. 3 to direct a flow of blood within thesupport structure 22.

In the embodiment of the invention illustrated in FIG. 4, the number ofconduits utilized to conduct blood to the implant is different than thenumber of conduits utilized to conduct blood from the implant. Inaddition, the implant 20 has a complex configuration formed by flat andarcuate surfaces. A multi-piece barrier is provided in the implant todirect the flow of blood.

In the embodiment of the implant 20 illustrated in FIG. 4, a singlearteriole 32 conducts a flow of blood to the support structure 22. Aplurality of venules 34 conduct the flow of blood from the supportstructure 22. Although only two venules 34 have been illustrated in FIG.4, it should be understood that a greater number of venules may beprovided if desired. Of course, a greater number of arterioles 32 couldalso be connected with the support structure 22 if desired. The numberof arterioles 32 may exceed the number of venules 34 if desired.

A plurality of viable cells 24 are provided within the support structure22. A barrier 48 is provided within the support structure 22. In theembodiment of the invention illustrated in FIG. 4, the barrier 48 isformed of a plurality of pieces or sections. One section 56 of thebarrier 48 has a generally conical configuration. However, the section56 of the barrier 48 has an open left (as viewed in FIG. 4) end portionto enable blood from the arteriole 32 to flow through the leftward endportion of the generally conical section 56 of the barrier. In addition,the barrier 48 includes a flow splitter 58 which disperses a flow ofblood entering the open left (as viewed in FIG. 4) end of the conicalsection 56 of the barrier. The flow splitter section 58 of the barriermay be formed by a plurality of pieces or by a single piece. The flowsplitter section 58 may be aligned with the opening in the left end ofthe barrier 48 or may be offset relative to the opening. For example,the splitter section 58 could be formed by a plurality of spaced apartsections each of which is offset slightly from the central axis of theopening formed in the left (as viewed in FIG. 4) end portion of thesection 56 of the barrier 48.

It should be understood that the arteriole 32 and venules 34 may beconnected with the support structure 22 of FIG. 4 in any one of themanners previously discussed herein. Rather than connecting an arteriole32 and venules 34 with the implant 20 as it is positioned in thepatient's body, conduits may extend from the support structure 22 and beconnected with one or more arteries and/or one or more veins in thepatient's body. It should be understood that either a greater or lessernumber of arterioles 32 and/or venules 34 may be connected with thesupport structure 22. The arterioles 32 and venules 34 may be connectedwith the support structure in any one of the manners previouslymentioned herein.

Organ Implant

It is contemplated that the implant 20 of FIGS. 1-4 may be positioned ineither soft or hard tissue in a patient's body. It is believed that itmay be desired to position one or more of the implants 20 in an organ ina patient's body. If this is done, the implant may be provided with oneor more side walls 40 having a configuration which corresponds to aconfiguration of the exterior surface of the organ.

Although it is contemplated that the implants 20 of FIGS. 1-4 could beutilized in association of any one of the many different organs in apatient's body, the implants are described in conjunction with a kidney66 (FIG. 5) disposed in the patient's body. It should be understood thatthe kidney 66 is only an example of one specific organ, that is, afunctional unit of cells, with which the implants of FIGS. 1-4 may beassociated.

The kidney 66 has a renal artery 68 through which blood is conducted tothe kidney. In addition, the kidney 66 has a renal vein 70 through whichblood is conducted from the kidney. A ureter 72 conducts urine from thekidney 66 to the patient's bladder. The renal artery 68, renal vein 70and ureter 72 are connected with a renal capsule 74.

When a kidney 66 becomes damaged by trauma and/or disease, it may bedesired to rejuvenate the kidney through the use of one or more implantscorresponding to the implants 20 of FIGS. 1-4. The implants 20 may bepositioned in a spaced apart relationship in the kidney 66 or positionedadjacent to each other. The specific location and arrangement of theimplants 20 in the kidney 66 will depend upon the extent and type ofdamage which the kidney has incurred.

The size and number of the implants positioned in the kidney 66, as wellas their location in the kidney can be varied in the manner believed tobe the best remedy for damage to the kidney. For example, a plurality ofthe implants 20 (FIGS. 1-4) may be positioned at spaced apart locationsin the kidney 66 (FIG. 6). Alternatively, the plurality of the implants20 may be positioned in engagement with each other at selected locationsin the kidney 66. Since the implants 20 are relatively small, thelocations where they are positioned in the kidney 66 can be selected tobest compensate for the damage incurred by the kidney.

When a single implant 20 is to be positioned in the kidney, the implantmay be connected with blood vessels in the kidney in the mannerpreviously described in conjunction with FIGS. 1-4 herein.Alternatively, a plurality of the implants 20 may be connected in serieswith each other so that blood flows from one implant to the nextsucceeding implant. As was previously mentioned herein, the implants 20may be connected in parallel with each other and with an artery whichsupplies blood to the implants and a vein which receives the blood fromthe implants. As was also previously mentioned, the implants 20 may beassociated with any desired organ in the patient's body. The kidney 66of FIGS. 5 and 6 is only representative of many organs in a patient'sbody.

When an implant 20 is to be positioned in the kidney 66, a recess oropening having a configuration corresponding to the configuration of theimplant is cut into the kidney. The implant 20 is then connected withblood vessels in the kidney 66 and is positioned in the opening (FIG.6). The opening may be sized so as to accept a single implant 20 or aplurality of implants. If the opening is sized to accept a singleimplant 20, the size of the single implant may be either relativelysmall or relatively large depending upon the damage which has beenoccurred by the kidney.

Under certain circumstances, it is believed that it may be desired toremove a section, that is a relatively large piece of a kidney. Whenthis has been done, a single implant 20 having a configurationcorresponding to the configuration of the removed section of the kidneymay be implanted at the location where the section was removed from thekidney. Since the relatively large implant 20 has the same configurationas the exterior surface of the kidney, when tissue grows into theimplant, the implant will form a portion of the kidney having the sameconfiguration as the section which was removed from the kidney.

When one or more implants 20 are to be positioned in the kidney 66, theviable cells 24 may include renal cells having characteristics ofreplaced cells in the kidney. Some of the viable cells in the implants20 may be stromal cells and/or fibroblast. Depending upon the locationwhere the implants 20 are positioned in the kidney, some of the viablecells 24 may be endothelial cells. Thus, stromal cells, renal cells, andendothelial cells may be positioned on a single implant 20 which isconnected with the kidney 66. Of course, other types of cells may bepositioned on the implant if desired.

Although the implants 20 have been illustrated in FIG. 6 as beingpositioned in the kidney 66, it is contemplated that the implants 20 maybe positioned in a different organ if desired. For example, the implants20 may be positioned in a patient's heart or one or more of the bones ofthe patient's skeleton. It is contemplated that the implants 20 may beused for applications other than partial or total organ replacement.Thus, the implant 20 may be located at any desired location in eitherhard or soft tissue in the patient's body.

Organ Replacement

It is contemplated that it may be desired to replace an entire organrather than a portion of the organ. When an organ is to be replaced, asupport structure 22 having a configuration corresponding to theconfiguration the organ to be replaced is formed. This support structure22 may be naturally formed or synthetically formed. The organ to bereplaced may be any one of the organs in the patient's body.

Assuming that the kidney 66 is the organ in a patient's body to bereplaced, it may be desired to form a support structure having aconfiguration corresponding to the configuration of the kidney 66. Whenit is desired to utilize a naturally formed support structure having theconfiguration of a kidney, a kidney 66 is obtained from a body. Thekidney 66 may be obtained from a patient's own body, from the body ofanother living human, from a cadaver (dead human body), or from a livingor dead animal.

When a kidney is used to form the support structure, it may be desiredto render the organ non-antigenic. Accordingly, any living cells on akidney 66 removed from a living donor may be killed with a cytotoxicsolution, such as a strong saline solution. Alternatively, the livingcells may be killed by radiation. Of course, other methods could beutilized to kill the living cells.

Assuming that the kidney 66 is to be obtained from a cadaver, the renalartery 68, renal vein 70 and ureter 72 are severed and the kidney 66 isremoved from the cadaver. Dead cells and/or other tissue are removedfrom the cadaver kidney to leave a collagen matrix having aconfiguration corresponding to the configuration of the kidney in thecadaver. The collagen matrix may have a relatively large portion with aconfiguration corresponding to the configuration of the renal capsule 74(FIG. 5), and three tubular conduits corresponding to the renal artery68, renal vein 70 and ureter 72.

The collagen matrix is utilized as a support structure 22 for viablecells, corresponding to the viable cells 24 of FIGS. 1-4. It iscontemplated that the viable cells 24 will be different types of cellsand will be placed at various locations in the collagen matrix formingthe support structure 22 made from the cadaver kidney. For example,renal cells may be positioned in the portion of the collagen matrixformed by the cadaver kidney corresponding to the renal capsule 74.Endothelial cells may also be positioned on the portion of the collagenmatrix corresponding to the renal capsule 74 and on the portions of thecollagen matrix corresponding to the renal artery 68, renal vein 70 andureter 72. In addition, stromal cells may be positioned on the portionof the collagen matrix corresponding to the renal capsule 74, renalartery 68, renal vein 70 and ureter 72. Fibroblast and mesenchymal cellsmay also be placed on the support structure 22 formed from the cadaverkidney. In addition, materials for promoting growth of tissue may bepositioned on the support structure.

Once the viable cells 24 have been positioned on the collagen matrixsupport structure 22 formed from the cadaver kidney, the result is areplacement kidney 66. The replacement kidney 66 may be formed at alocation spaced from an operating room. After the replacement kidney 66has been formed, it may be transported to the operating room andimplanted in the patient.

To implant the replacement kidney 66 in the patient, the damaged kidneyin the patient is removed. Removal of the damaged kidney 66 from thepatient would involve severing the renal artery 68, renal vein 70 andureter 72 connected with the damaged kidney in the patient.

After the damaged kidney 66 has been removed from the patient, the renalartery 68 of the replacement kidney is connected with the portion of therenal artery remaining in the patient's body. Similarly, the renal vein70 of the replacement kidney 66 is connected with the portion of therenal vein remaining in the patient's body. In addition, the ureter 72on the replacement kidney 66 is connected with the portion of the ureterremaining in the patient's body. The replacement kidney 66 is then movedto a desired location in the patient's body.

Blood is conducted to the replacement kidney 66 through the remainingportion of the patient's renal artery 70 and the portion of the renalartery associated with the replacement kidney. Blood is conducted fromthe replacement kidney 66 through the portion of the renal vein 70associated with the replacement kidney and the remaining portion of thepatient's renal vein. Urine is conducted from the replacement kidney 66through the portion of the ureter 72 associated with the replacementkidney and to the remaining portion of the patient's ureter.

Although the foregoing description has related to replacement of akidney 66, the method described herein may be used in association withthe replacement of the other organs in a patient's body. Thus, themethod described herein may be used in conjunction with the replacementof an adrenal gland, heart, liver, bone, pancreas, or other organ.

Rather than utilizing the collagen matrix of the cadaver kidney to atleast partially form the support structure for a replacement kidney, thecadaver kidney may be utilized as a pattern to form a mold cavity havinga configuration corresponding to the configuration of the cadaverkidney. Thus, the cadaver kidney 66 (FIG. 7) may be enclosed with moldmaterial 80. The mold material may be divided into two segments 82 and84 (FIG. 7). The pattern 66 is enclosed by the mold material 80 and themold material is solidified around the pattern to form the two segments82 and 84.

Once the mold material has solidified around the kidney pattern 66, thekidney pattern is separated from the mold. Once the kidney pattern 66has been separated from the mold 62, the two segments 82 and 84 may beinterconnected to form a mold assembly which defines a recess or cavity88. The recess or cavity 88 has a configuration which corresponds to theconfiguration of the pattern kidney along with the attached portions ofthe renal artery 68, renal vein 70, and ureter 72.

The kidney pattern 66 may be obtained from a patient, from anotherliving human, from a cadaver, or from an animal. It is believed that itmay be preferred not to use the patient's own kidney as the kidneypattern 66 since the configuration of the patient's own kidney may beunsuitable. If desired, an artificial pattern, having a configurationcorresponding to a desired configuration of a kidney may be used as apattern for the mold cavity 88.

Once the mold cavity 88 has been formed by separating the mold segments82 and 84 from the natural or artificial kidney pattern 66, a syntheticsupport structure 22 is formed in the mold cavity 88. This may beaccomplished by injecting a material into the recess or cavity 88 whilethe two mold segments 82 and 84 are interconnected. The materialinjected into the mold cavity 88 may be either biodegradable ornonbiodegradable. The material injected into the mold cavity 88solidifies with an open cell porous structure. Synthetic collagen orpolylatic acid with a chemical blowing agent or entrained gas may beutilized to form the porous support structure.

When the material injected into the mold cavity has solidified with anopen cell porous structure, it will have a configuration correspondingto the configuration of the renal capsule 74 of the kidney pattern 66,the renal artery 68, renal vein 70 and ureter 72 connected with therenal capsule of the kidney pattern. The resulting support structure 22is formed as one piece of porous material.

The selected viable cells, corresponding to viable cells 24 (FIGS. 1-4),are positioned in small openings or pores of the cast porous supportstructure 22 having the configuration of a kidney. It is contemplatedthat the viable cells 24 may be positioned in any one of many differentknown ways on the porous support structure 22 having the configurationof a kidney. One way in which the viable cells may be positioned on theporous support structure 22 is to inject a liquid solution containingthe viable cells 24 into the porous support structure 22. The viablecells 24 would be the deposited in the porous of the support structure22 as the liquid dries. A different solution with different viable cellsmay be injected in different portions of the porous support structure22. The viable cells 24 may be any of the viable cells previouslymentioned herein. Of course, the viable cells 24 would be deposited onthe porous support structure 22 in accordance with the desired tissuestructure to be obtained by growth of the viable cells. Other knownmethods of positioning viable cells on a support structure may beutilized if desired.

Rather than forming a support structure 22 for the synthetic replacementorgan of a porous material, it is contemplated that the supportstructure may be formed of intertwined strands or filaments (FIG. 11).The strands or filaments may be woven together in the recess or cavity88 formed by the mold segments 82 and 84. This would result in theintertwined filaments or strands having an overall configurationcorresponding to the configuration of the pattern kidney 66 of FIG. 7.

The intertwined strands or filaments would define relatively smallspaces in which the viable cells 24 would be positioned. The viablecells 24 may be positioned on the woven support structure by injecting asolution containing the viable cells into the spaces or recesses formedby the intertwined strands of the support structure. Of course,different types of viable cells 24 would be positioned at differentlocations in the woven support structure. Any one of the desired typesof viable cells 24 previously mentioned herein may be utilized. Itshould be understood that the specific viable cells 24 positioned at aspecific location on the woven support structure 22 would depend uponthe desired characteristics of the tissue to be grown at that location.

The strands of the woven support structure 22 may be either a naturallyoccurring materials or synthetic materials. The strands of the wovensupport structure 22 may be biodegradable or nonbiodegradable. It iscontemplated that strands of synthetic or natural collagen may beutilized to form the woven support structure 22 on which the viablecells 24 are positioned. If desired, the exterior of the woven supportstructure 22 may be sealed by encapsulating the woven support structurewith a material through which blood cannot easily flow. The materialused to encapsulate the woven support structure may be eitherbiodegradable or nonbiodegradable. It is contemplated that a suitablepolymeric material, such as polylatic acid, may be utilized. It isbelieved that blood vessels, such as capillaries, will grow throughsmall passages or channels formed in the woven support structure.

The foregoing description has been a conjunction with the replacement ofa kidney 66 in a patient. It is contemplated that the procedurespreviously described herein could be utilized in conjunction with areplacement of many different types of organs. For example, a patient'spancreas may be replaced. If the patient's pancreas is replaced, viableendocrine cells and viable exocrine cells may be positioned on thesupport structure 22. In addition, islets of Langerhans could bepositioned on the support structure.

It is contemplated that the entire pancreas or only a portion of thepancreas may be replaced. If desired, relatively small implants,corresponding to the implants 20 of FIGS. 1-4, may be positioned in thepancreas. The specific types of viable cells, that is islets ofLangerhans, endocrine, and/or exocrine cells would be positioned at thelocation on the support structure 20 where the corresponding tissues areto be grown.

It is contemplated that a portion of the patient's hard tissue (bone)may be replaced using the foregoing methods. If this is to be done, asupport structure 22 having a configuration corresponding to aconfiguration of at least a portion of one of the bones in the patient'sskeleton would be replaced. The viable cells 24 positioned on thesupport structure 22 may be osteoblasts and/or mesodermal cells. Inaddition, osteochondral cells may be positioned on the support structure22. Myoblasts may be utilized in association with the support structure22 to promote the growth of muscular tissue.

Partial Replacement of an Organ

Rather than replacing an entire organ, it is contemplated that a portionof an organ may be replaced. In FIG. 8, a segment of a blood vessel 96is to be replaced. However, it should be understood that the method ofthe present invention may be used to replace portions of an organ otherthan a blood vessel. The segment of the blood vessel 96 has beenselected to be representative of a portion of many different organs in apatient's body.

When a segment of a blood vessel 96 is to be replaced, it is believedthat the blood vessel will be severed at cuts 98 and 100 disposed atspaced apart locations along the length of the blood vessel. The portionof the patient's blood vessel between the cuts 98 and 100 is removed. Animplant 104 is positioned between the cuts and connected with segments106 and 108 of the blood vessel 96. The implant 104 is tubular and has acylindrical configuration.

The implant 104 includes a cylindrical support structure 112 having thesame general construction as the support structure 22 of FIGS. 1-4. Thesupport structure 112 has a plurality of openings or recesses in whichviable cells 114 are disposed. In the embodiment of FIG. 8, the supportstructure 112 is enclosed by an outer layer 116 which blocks a radiallyoutward flow of blood from the inside of the tubular cylindrical implant104.

The segments 106 and 108 of the blood vessel 96 may be connected withthe support structure 112 by stitching or by adhesive. Of course, thesupport structure 112 could be connected with the segments 106 and 108of the blood vessel 96 in a different manner if desired.

It is contemplated that the viable cells 114 may include endothelialcells, mesenchymal cells, and/or smooth muscle cells. It should beunderstood that more than one type of cell may be mounted on the supportstructure 112. Tissue growth induction materials may be provided on thesupport structure 112 to promote a growth of tissue between the segments106 and 108 of the blood vessel 96 and the support structure 112. Duringa flow of blood through the blood vessel 96, the viable cells 114 on thesupport structure 112 are exposed to the flow of blood.

If the blood vessel 96 is a vein, it may be desired to provide a checkvalve in association with the implant 104. The check valve may be formedby flexible flaps which are pressed against each other to prevent a backflow of blood in much the same way as in naturally occurring veins. Thecheck valve may be formed by flaps of synthetic material or of a matrixof collagen or other materials in which viable smooth muscle cells aredisposed. If viable smooth muscle cells are provided on flaps formed ofa support structure of natural or synthetic collagen or other material,viable smooth muscle cells on the support structure 112 and the smoothmuscle cells on the check valve may grow together to provide a checkvalve having the same general construction as a naturally occurringcheck valve in a vein or other organ.

Rather than being connected with a segment of a blood vessel, one end ofthe implant 104 may be connected with another organ, such as a heart.Thus, the patient's blood vessel may be severed adjacent to the heart.The segment 106 of the blood vessel would be connected with one axialend portion of the support structure 112 of the implant 104. Theopposite axial end portion of the tubular cylindrical implant 104 wouldbe connected directly with the patient's heart. Of course, the implant104 could be associated with organs other than a patient's heart. Itshould also be understood that the implant 104 may be positioned in ablood vessel at a location remote from other organs.

During connection of the segments 106 and 108 of the blood vessel 96with the implant 104, it may be advantageous to utilize an expandablemember 122 to align the segments 106 and 108 of the blood vessel 96 withthe implant 104 in the manner illustrated schematically in FIG. 9. Whenthe expandable member 122 is in a contracted condition, it is insertedthrough a relatively small slit in the segment 108 of the blood vessel96 at a location remote from the cuts 98 and 100 where the implant 104is to be positioned. The expandable member 122 is moved axially alongthe blood vessel 96 to a location adjacent to the cut 100. While theexpandable member is in a contracted condition, it is moved from thesegment 108 of the blood vessel 96 into the implant 104. The leading endportion of the expandable member 122 is then moved from the implant 104into the segment 106 of the blood vessel 96.

Once the expandable member has been positioned so that it extendsbetween the segments 106 and 108 of the blood vessel 96 and through theimplant 104 (as shown in FIG. 9), the expandable member is expanded. Asthe expandable member 122 is expanded, the end portions of the segments106 and 108 of the blood vessel 96 adjacent to the implant are expandedand moved into alignment with the implant 104. As the expandable member122 expands radially outward from a contracted condition to the expandedcondition illustrated schematically in FIG. 9, a collapsed or contractedend portion of the segment 106 of the blood vessel 96 adjacent to thecut 98 is expanded. As this occurs, the end portion of the blood vesselsegment 106 adjacent to the cut 98 moves radially outward and is alignedwith an adjacent end portion of the cylindrical tubular implant 104. Atthe same time, the opposite end portion of the expandable member 122 isexpanded. As this occurs, the end portion of the segment 108 of theblood vessel 96 adjacent to the cut 100 is expanded. Thus, the endportion of the blood vessel 108 is expanded from a collapsed orcontracted condition to the expanded condition illustrated in FIG. 9 byexpansion of the expandable member 122.

As the expandable member 122 expands, a central portion of theexpandable member, that is a portion of the expandable member enclosedby the implant 104, expands into engagement with an inner side surfaceof the implant 104. As this occurs, annular axially opposite ends of theimplant 104 are aligned with the cuts 98 and 100 on the ends of theblood vessel segments 106 and 108.

While the blood vessel segments 106 and 108 are aligned with the implant104, the cut 98 on the end portion of the blood vessel 106 is connectedto the annular end portion of the implant 104. The segment 106 of theblood vessel 96 may be connected with the implant 104 by stitching, bysuitable adhesive, or by other known methods. Similarly, the cut 100 onthe end portion of the segment 108 of the blood vessel 96 is connectedto the implant 104 by stitching, a suitable adhesive, or other knownmethods.

Once the blood vessel segments 106 and 108 have been connected with theimplant 104, the expandable member 122 is contracted. The contractedexpandable member 122 is then pulled out of the blood vessel 96 throughthe same small opening through which the contracted expandable memberwas moved into the blood vessel.

The expandable member 122 may be expanded by a mechanical device or byfluid pressure. Thus, the expandable member may have a device whichexpands through a mechanical action in a manner similar to thatdisclosed in U.S. Pat. No. 5,685,826. Alternatively, the expandablemember 122 may be expanded under the influence of fluid pressure in themanner similar to that disclosed in U.S. Pat. No. 6,358,266. Theexpandable member 122 may be expanded in the manner similar to thatdisclosed in U.S. Pat. No. 6,338,730.

Although it is believed that many different types of known expandabledevices may be utilized for the expandable member 122, the expandablemember may be a balloon which is expanded under the influence of eithergas or liquid pressure. The gas or liquid pressure may be conducted tothe balloon through a conduit 128 (FIG. 9). The conduit 128 may havesufficient rigidity so as to be able to move the expandable member 122,specifically, a balloon, along the blood vessel 96 and through theimplant 104 to the position illustrated schematically in FIG. 9 whilethe expandable member is in a contracted condition.

Once the expandable member has been expanded, under the influence offluid pressure conducted through the conduit 128, the implant 104 andsegments 106 and 108 of the blood vessel 96 are interconnected. Thefluid is then exhausted from the expandable member 122 through theconduit 128 to contract the expandable member. The contracted expandablemember is then pulled out of the blood vessel 96 under the influence offorce transmitted through the conduit 128.

Rather than using a single expandable member 122, a plurality ofexpandable members 134 and 136 (FIG. 10) may be utilized to align theimplants 104 and the end portions 106 and 108 of the blood vessel 96.The members 134 and 136 may be expanded by mechanical mechanisms or maybe expanded under the influence of fluid pressure in the mannerpreviously explained in conjunction with the expandable member 122 ofFIG. 9.

The expandable member 134 is inserted into the segment 106 of the bloodvessel 96 when the expandable member is in a contracted condition. Thecontracted expandable member 134 is inserted through a small slit formedin the blood vessel 106 at a location spaced from the cut 98. Thecontracted expandable member 134 is pushed along the segment 106 of theblood vessel by a conduit 140 connected with the contracted expandablemember 134. The leading end portion of the contracted expandable member134 is moved from the segment 106 of the blood vessel 96 into theimplant 104.

Similarly, the contracted expandable member 136 is moved into thesegment 108 of the blood vessel 96 through a small slit at a locationspaced from the cut 100. The contracted expandable member 136 is pushedalong the segment 108 of the blood vessel 96 by a conduit 144. Theleading end portion of the contracted expandable member 136 is movedfrom the segment 108 of the blood vessel 96 into the implant 104.

After both of the contracted expandable members 134 and 136 have beenposition with their leading end portions in the implant 104, they areexpanded. Expansion of the expandable member 134 expands the end portionof the blood vessel segment 106 and moves it into alignment with theadjacent end portions of the implant 104. Similarly, expansion of theexpandable member 136 expands the end portion of the blood vesselsegment 108 and moves it into alignment with the end portion of theimplant 104. This results in the implant 104 and the segments 106 and108 of the blood vessel 96 being held in axial alignment with eachother, in the manner illustrated schematically in FIG. 10, by theexpanded expandable members 134 and 136.

While the implant 104 and segments 106 and 108 of the blood vessel 96are held in alignment by the expanded expandable members 134 and 136,the end portions of the segments of the blood vessel are connected withthe implant 104. Thus, the annular cut end 98 of the segment 106 to theblood vessel 96 is connected to one annular end of the implant 104. Theannular cut end 100 of the blood vessel segment 108 is connected to theopposite annular end of the implant 104. The blood vessel segments 106and 108 may be connected with the implant 104 by stitches, a suitableadhesive, or another known manner.

Once the blood vessel segments 106 and 108 have been connected with theimplant 104, the expandable members 134 and 136 are contracted. Thecontracted expandable members 134 and 136 are then pulled from the bloodvessel segments 106 and 108 through the small slits which they enter theblood vessel segments.

Although the expandable members 134 and 136 may be mechanicallyexpandable members, it is believed that it may be preferred to expandthe expandable members under the influence of fluid pressure, that isunder the influence of pressure transmitted through either a gas or aliquid. The fluid pressure is conducted to the expandable members 134and 136 through the conduits 140 and 144.

In the embodiment of the invention illustrated in FIGS. 9 and 10, theexpandable members 122, 134 and 136 are illustrated in conjunction withthe connecting of segments 106 and 108 with a blood vessel 96 with animplant 104. However, it is contemplated that implant 104 could beconnected directly with an organ, such as a heart. For example, if theleft (as viewed in FIG. 9) end of the implant 104 is to be connectedwith a heart, the segment 106 of the blood vessel 96 would be omittedand the left or leading end portion of the balloon 122 (FIG. 9) insertedinto an opening formed in the heart. This would align the implant 104with the opening in the heart. The implant 104 would then be connecteddirectly to the heart with a suitable adhesive, stitching or other knowndevice. The segment 108 of the blood vessel 96 would then be connectedwith the implant 104 while the expandable member 122 maintains thesegment 108 of the blood vessel 96 in alignment with the implant 104.

Although the expandable members 122, 134 and 136 have previously beendescribed herein in conjunction with the connecting of an implant 104with at least one of the blood vessel segments 106 and/or 108, it iscontemplated that the expandable members may be utilized in thepositioning many different types of implants relative to many differenttypes of tissue. For example, expandable members similar to expandablemembers 122, 134 and 136 may be utilized in conjunction with theconnection of ducts with organs or with implanting of a segment in aduct. Alternatively, expandable members, similar to the expandablemembers 122, 134 and 136, may be utilized during the connection of animplant in a portion of a patient's intestine or during the connectionof an implant with one end of an intestine and a stomach.

It is contemplated that an implant may be positioned in a bone in apatient's body using expandable members similar to the expandablemembers 122, 134 and 136. This may be done by inserting an expandablemember through an opening in the implant. The expandable member wouldextend from the implant into the bone to align the bone with theimplant. Once the bone and the implant have been interconnected theexpandable member would be withdrawn from the opening through which itwas inserted into the implant. Once this has been accomplished, theinterior of the bone may be filled with an artificial cancellous bone orwith a slurry containing osteoblast and bone growth promoting materials.

CONCLUSION

In view of the foregoing description, it is apparent that the presentinvention provides a method of implanting viable cells 24 into a body ofa patient. The viable cells 24 may be positioned on a support structure22. One or more blood vessels 28 in a patient's body may be connectedwith the support structure 22 at one or more locations. The viable cells24 on the support structure 22 may be exposed to blood flow in thesupport structure. One or more support structures 22 may be provided andpositioned in the patient's body.

The support structure 22 may be formed in many different ways. One wayin which the support structure 22 may be formed is by removing an organ66 or a portion of an organ from a body, either the patient's own bodyor another body. Cells and/or other tissue may be removed from the organ66 or portion of the organ to leave a support structure 22 having aconfiguration corresponding to the configuration of the organ or portionof an organ. Viable cells 24 are positioned on the support structure 22.The support structure 22, which has a configuration corresponding to theconfiguration of an organ 66 or portion of an organ, is positioned inthe patient's body with the viable cells 24 disposed on the supportstructure 22. Blood vessels 28 may advantageously be connected with thesupport structure 22 as it is positioned in the patient's body. Thesupport structure 22 may correspond to an entire organ 66 or only aportion of an organ.

The support structure 22 may be formed by using an organ 66 or portionof an organ from a body, that is either the patient's body or anotherbody, as a pattern. Alternatively, the pattern may be syntheticallyconstructed to have a configuration corresponding to the generalconfiguration of an organ 66 or portion of an organ in a patient's body.The pattern is at least partially enclosed with mold material 80. Thepattern and mold material are subsequently separated to leave a moldcavity 88. The synthetic support structure 22 is subsequently shaped inthe mold cavity 88. The synthetic support structure may be formed as aunitary member or formed by one or more intertwined strands.

One or more expandable members 122, 134 and/or 136 may be utilized toalign an implant 104 and tissue 96 in a patient's body. For example, oneor more balloons may be utilized to align portions 106 and 108 of ablood vessel with a segment 104 which is to be implanted into the bloodvessel.

It should be understood that the present invention has a plurality ofdifferent features which may be utilized separately or in variouscombinations. It is also contemplated that the various features of theinvention may be utilized with known features from the prior art.Although specific combination of features have been described herein, itis contemplated that other combinations of features will be apparent tothose skilled in the art and will be formed.

Furthermore, although certain applications are described herein, thoseof ordinary skill in the art will appreciate other applications for thepresent invention. For example, the scaffold can be introduced with anon-surgical procedure by a radiologist or other practitioner ratherthan a formal surgical procedure. The procedure could utilize Millguidance (open, standing vertical, etc.), ultrasonic guidance, computernavigation, radiographic guidance, PET scanning. The Mill may be akinematic Mill to isolate the organ or Mill with external pressureallowing one to visualize the organ or tissue type specifically and thenimplant the scaffold under a pressurized approach so that the externalpressure applied would hold the organ in the position while the scaffoldwould be stabilized.

In view of the foregoing, it should be understood that variations andmodifications within the spirit and scope of the invention might occurto those skilled in the art to which the invention pertains.Accordingly, all expedient modifications readily attainable by oneversed in the art from the disclosure set forth herein that are withinthe scope and spirit of the present invention are to be included asfurther embodiments of the present invention. The scope of the presentinvention is accordingly defined as set forth in the appended claims.

1. A method of creating a non-biologic surgical implant configured forimplantation onto a portion of a bone of a patient, the methodcomprising: constructing a non-biologic three dimensional compositesupport structure integrally formed as one piece, the non-biologic threedimensional composite support structure including a nonbiodegradablematerial and having a porous construction with a plurality of passages,wherein the support structure is constructed to have a configurationcorresponding to at least one of a bone and a portion of a bone to bereplaced in the patient; and providing the non-biologic threedimensional composite support structure to enable placement of thenon-biologic three dimensional composite support structure in thepatient, wherein an outer surface of the support structure is configuredto be pressed adjacent the bone, wherein the non-biologic threedimensional composite support structure is configured to be positionedin the body to promote growth of tissue in the body of the patient intoat least a portion of the non-biologic three dimensional compositesupport structure by having at least a portion of the porous constructadjacent the bone enabling biologic structures to grow into theplurality of passages in the porous construction to securely connect thesupport structure in place in the body of the patient.
 2. The methodaccording to claim 1, wherein the non-biologic three dimensionalcomposite support structure may be configured to be positioned in thepatient by a surgical robotic mechanism.
 3. The method according toclaim 1, wherein the non-biologic three dimensional composite supportstructure may be constructed of different materials.
 4. The methodaccording to claim 1, wherein viable cells may be layered on thenon-biologic three dimensional composite support structure.
 5. Themethod according to claim 4, wherein the viable cells include cells thatare at least one of fibroblast cells, osteochondral cells, osteoblastcells, osteoclast cells, mesodermal cells, and myoblast cells.
 6. Themethod according to claim 1, wherein the tissue growth promoted by thenon-biologic three dimensional composite support structure is at leastone of bone, cartilage, and muscle.
 7. The method according to claim 1,wherein osteoinductive growth factors including at least one of IGF(insulin-like growth factors), TGF (transforming growth factors), FGB(fibroblast growth factors), EGF (epidermal growth factors), BMP (bonemorphogenic proteins), and PDGF (platelet-derived growth factors) may beadded to the non-biologic three dimensional composite support structure.8. The method according to claim 1, wherein at least one type ofantibiotic may be added to the non-biologic three dimensional compositesupport structure.
 9. A non-biologic implant for replacing at least aportion of a bone of a patient, the non-biologic implant comprising: anon-biologic three dimensional composite support structure integrallyformed as one piece, the non-biologic three dimensional compositesupport structure including a nonbiodegradable material and having aporous construction with a plurality of passages, wherein thenon-biologic three dimensional composite support structure isconstructed to have a configuration corresponding to at least one of abone and a portion of a bone to be replaced in a patient, wherein thenon-biologic three dimensional composite support structure is configuredto promote growth when an outer surface of the porous support structureis positioned adjacent the bone, and wherein the non-biologic threedimensional composite support structure is configured to be positionedin the body to promote growth of tissue in the body of the patient intoat least a portion of the non-biologic three dimensional compositesupport structure by having at least a portion of the porous constructadjacent the bone, enabling biologic structures to grow into theplurality of passages in the porous construction to securely connect thesupport structure in place in the body of the patient.
 10. Thenon-biologic implant according to claim 9, wherein the non-biologicthree dimensional composite support structure may be configured to bepositioned in the patient by a surgical robotic mechanism.
 11. Thenon-biologic implant according to claim 9, wherein the non-biologicthree dimensional composite support structure may be constructed ofdifferent materials.
 12. The non-biologic implant according to claim 9,wherein viable cells may be layered on the non-biologic threedimensional composite support structure.
 13. The non-biologic implantaccording to claim 12, wherein the viable cells include cells that areat least one of fibroblast cells, osteochondral cells, osteoblast cells,osteoclast cells, mesodermal cells, and myoblast cells.
 14. Thenon-biologic implant according to claim 9, wherein the tissue growth ispromoted by the non-biologic three dimensional composite supportstructure is at least one of bone, cartilage, and muscle.
 15. Thenon-biologic implant according to claim 9, wherein osteoinductive growthfactors including at least one of IGF (insulin-like growth factors), TGF(transforming growth factors), FGB (fibroblast growth factors), EGF(epidermal growth factors), BMP (bone morphogenic proteins), and PDGF(platelet-derived growth factors) may be added to the non-biologic threedimensional composite support structure.
 16. The non-biologic implantaccording to claim 9, wherein at least one type of antibiotic may beadded to the non-biologic three dimensional composite support structure.17. A non-biologic implant for replacing at least a portion of an organof a patient, the non-biologic implant comprising: a non-biologic threedimensional composite support structure integrally formed as one piece,the non-biologic three dimensional composite support structure includinga nonbiodegradable material and having a porous construction with aplurality of passages, wherein the non-biologic three dimensionalcomposite support structure is constructed to have a configurationcorresponding to at least one of an organ and a portion of an organ tobe replaced in a patient, wherein the non-biologic three dimensionalcomposite support structure is configured to promote growth when anouter surface of the porous support structure is positioned adjacent theorgan, and wherein the non-biologic three dimensional composite supportstructure is configured to be positioned in the body to promote growthof tissue in the body of the patient into at least a portion of thenon-biologic three dimensional composite support structure by having atleast a portion of the porous construct adjacent the organ, enablingbiologic structures to grow into the plurality of passages in the porousconstruction to securely connect the support structure in place in thebody of the patient.
 18. The non-biologic implant according to claim 17,wherein the non-biologic three dimensional composite support structuremay be configured to be positioned in the patient by a surgical roboticmechanism.
 19. The non-biologic implant according to claim 17, whereinthe non-biologic three dimensional composite support structure may beconstructed of different materials.
 20. The non-biologic implantaccording to claim 17, wherein viable cells may be layered on thesynthetic three dimensional composite support structure.
 21. Thenon-biologic implant according to claim 17, wherein the tissue growthpromoted by the non-biologic three dimensional composite supportstructure is at least one of kidney, pancreas, and heart tissue.
 22. Thenon-biologic implant according to claim 17, wherein at least one type ofantibiotic may be added to the non-biologic three dimensional compositesupport structure.